MAUDE Adverse Event Report: DEPUY SPINE INC EAGLE+/SWIFT+ SCR OVRSZ ST, 16; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	183651016
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The surgeon was re-positioning a plate.He had a difficult time remounting the screws and broke or stripped some of the drivers.Upon inspection some of the threads on the screws were messed up so the surgeon did not feel comfortable putting those back in and that they would still be blocked by the clocking ring.
Additional Manufacturer Narrative
Product complaint # (b)(4).The returned screw feature damage to its threads.Sections of the thread are flattened and/or peeled away from the shank of the screw.Another section is broken away from the shank, but still attached to the screw as a whole at a single point on the body of the screw.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the damage to the thread of the screw cannot be determined from the sample and the information provided.A potential root cause may be inserting the screw into the plate at an extreme angle.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EAGLE+/SWIFT+ SCR OVRSZ ST, 16
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7141882
• Report Number: 1526439-2017-50126
• Device Sequence Number: 1109585
• Product Code: KWQ
• UDI-Device Identifier: 10705034095882
• UDI-Public: 10705034095882
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 183651016
• Device Lot Number: AVFF5G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR